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At Veristat, we recently embarked on an ambitious journey alongside a biotech organization specializing in gene therapies for metabolic diseases. Our engagement entailed supporting their Phase I/II clinical study for a rare human genetic lysosomal...
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Precision and efficiency are key in the intricate world of CNS drug development. Veristat's recent collaboration with a clinical-stage biopharmaceutical company showcases an agile medical writing and project management approach, revolutionizing the...
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RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...
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Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...
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Veristat has experience in preparing more than 120 marketing applications. Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:
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When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?
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When a team faces multiple submissions in a short timeframe or even simultaneous submissions, uncertainty over timeline organization and the best way to utilize medical writers can be paralyzing.